How reducing tremor affects stigma in people with essential tremor
ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
University of Texas Southwestern Medical Center · NCT07430761
This study will see if lowering hand tremor with focused ultrasound thalamotomy reduces stigma-related distress and social problems in adults with essential tremor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07430761 on ClinicalTrials.gov |
What this trial studies
This is a before-and-after observational study of adults with essential tremor who undergo stereotactic thalamotomy using high-intensity focused ultrasound (HIFU) targeted by tractography. Participants complete three short questionnaires measuring stigma distress, stigma-related dysfunction, and tremor-related disability shortly before the procedure and again 11–18 months later. Changes in stigma scores will be compared with improvements in objective tremor severity and functional status to look for correlations. The questionnaires are brief (about 5 minutes total) and the study does not change clinical care.
Who should consider this trial
Good fit: Adults diagnosed with essential tremor by a movement disorder neurologist who are scheduled for HIFU thalamotomy for functionally significant tremor and can give informed consent.
Not a fit: People who do not undergo tremor-reducing thalamotomy, whose tremor does not improve after the procedure, or whose social concerns are unrelated to tremor visibility may not experience benefit.
Why it matters
Potential benefit: If successful, reducing tremor could lessen stigma-related distress and social dysfunction and thereby improve quality of life for people with essential tremor.
How similar studies have performed: Focused ultrasound thalamotomy has been shown to reduce tremor and improve function, but few prior studies have directly measured changes in stigma, so this question is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * People with ET as diagnosed by a movement disorder neurologist * Tremor of sufficient severity and impact on quality of life so as to justify a lesional brain procedure * Competent to consent to undergoing high intensity focused ultrasound thalamotomy targeted by 4-tract tractography * Provide verbal informed consent to this study of ET stigma Exclusion Criteria: * Patient declines to participate in this observational study
Where this trial is running
Dallas, Texas
- University of Texas Soouthwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Padraig E O'Suilleabhain, MD — University of Texas Southwestern Medical Center
- Study coordinator: Padraig E O'Suilleabhain, MD
- Email: padraig.osuilleabhain@utsouthwestern.edu
- Phone: 2146482943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Action Tremor, Stigma, Social, Essential tremor, stigma, thalamotomy, high intensity focused ultrasound